NCT03044587

Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer

Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer - An Open Label, Non-comparative, Randomized, Multicenter Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

AIO-YMO/HEP-0315 (NIFE) is an open label, non-comparative, randomized, multicenter phase II trial

Detailed description

The primary objective is to determine whether a combination of 5-FU and nal-IRI prolongs progression-free survival in patients with locally advanced or metastatic adenocarcinoma of the biliary tract

Conditions

• Adenocarcinoma Metastatic
• Biliary Tract Cancer
• Adenocarcinoma of the Biliary Tract
• Adenocarinoma Locally Advanced
• Non-Resectable Hepatocellular Carcinoma
• Intrahepatic Bile Duct Carcinoma
• Extrahepatic Bile Duct Carcinoma

Interventions

Type	Name	Description
DRUG	Arm NaI-IRI + 5-FU + Leucovorin (Arm A)	Nal-IRI (80 mg/m2 as a 1.5 hour infusion), 5-FU (2400 mg/m2 as 46 hour infusion) and Leucovorin (400 mg/m2 as 0.5 hour infusion) Cycle q2w
DRUG	Arm Cisplatin + Gemcitabine (Arm B)	Cisplatin (25 mg/m2 as 1 hour infusion on D1, D8) and Gemcitabine (1000 mg/m2 as 0.5 hour infusion on D1, D8) Cycle q3w

Timeline

• Start date: 2018-01-24
• Primary completion: 2022-01-01
• Completion: 2025-01-31
• First posted: 2017-02-07
• Last updated: 2025-10-01

Locations

1 site across 1 country: Germany